On May 4, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported recent business highlights and first quarter 2021 financial results (Press release, Sangamo Therapeutics, MAY 4, 2021, View Source [SID1234579172]).
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"This quarter, we have continued our focus on advancing our lead programs through clinical execution, regulatory interactions, and collaborations with our partners and investigators. We are pleased that enrollment has completed for Pfizer’s lead-in study for the hemophilia A Phase 3 AFFINE trial. Additionally, the EMA granted Orphan Designation and the FDA granted Fast Track Designation to BIVV003, now known as SAR445136, our cell therapy product candidate treating sickle cell disease partnered with Sanofi. Also, we initiated the STEADFAST study for our product candidate treating renal transplant rejection, which we believe is the first-in-human CAR-Treg clinical study," said Sandy Macrae, Chief Executive Officer of Sangamo. "Further, our research engine continued to be highly productive this quarter, advancing both our CAR-Treg programs for autoimmune disorders and our transcriptional regulation therapies for neurological diseases."
Recent Business Highlights
Completed enrollment of patients in Pfizer’s lead-in study to the registrational Phase 3 AFFINE clinical trial of giroctocogene fitelparvovec, a gene therapy product candidate for the treatment of severe hemophilia A, developed in collaboration with Pfizer.
Received Fast Track Designation from the FDA for BIVV003, now known as SAR445136, our cell therapy product candidate for the treatment of sickle cell disease, developed in collaboration with Sanofi. Also, the EMA granted Orphan Designation to SAR445136 based on early clinical data from three treated patients.
Initiated the Phase 1/2 STEADFAST clinical study evaluating TX200, a wholly-owned autologous HLA-A2 CAR-Treg cell therapy product candidate treating patients receiving a HLA-A2 mismatched kidney from a living donor. The first patient is expected to be enrolled in this study by the end of this year.
Published preclinical data on tau- and alpha-synuclein-targeted zinc finger transcriptional repressors in Science Advances and at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases (ADPD), respectively. Also, announced upcoming preclinical alpha-synuclein and C9ORF72 abstracts to be presented at the upcoming 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) on May 11, 2021.
First Quarter 2021 Financial Results
Consolidated net loss for the first quarter ended March 31, 2021 was $45.9 million or $0.32 per share, compared to a net loss of $42.9 million or $0.37 per share for the same period in 2020.
Revenues
Revenues for the first quarter ended March 31, 2021 were $26.3 million, compared to $13.1 million for the same period in 2020. The increase of $13.2 million in revenues was primarily due to the recognition of upfront license fees and research reimbursements under our collaboration agreements with Biogen and Novartis, which became effective in April and July 2020, respectively. These increases were partially offset by a decrease in revenue related to our hemophilia A collaboration with Pfizer, as a result of completion of our reimbursable activities in the fourth quarter of 2020.
GAAP and Non-GAAP operating expenses
Total operating expenses on a GAAP basis for the first quarter ended March 31, 2021 were $72.6 million compared to $57.6 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the first quarter ended March 31, 2021 were $65.1 million compared to $52.0 million for the same period in 2020.
The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses to support the advancement of our clinical trials and our new collaborations along with our increased headcount.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of March 31, 2021 were $629.5 million compared to $692.0 million as of December 31, 2020.
Guidance for 2021 Reiterated (initial guidance provided on February 24, 2021)
On a GAAP basis, we expect total operating expenses, including non-cash stock-based compensation expenses, to be in the range of approximately $285 million to $305 million.
On a non-GAAP basis, we expect total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $30 million, to be in the range of approximately $255 million to $275 million.
Conference Call
Sangamo will host a conference call today, May 4, 2021, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5714729. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5714729.